FDA.reportPublic FDA data

Atovaquone

Product NDC
50268-086
11-digit product format
502680086
Labeler code
50268
Product ID
50268-086_10fc4532-0b9f-4511-b0a2-bd7edd49cb47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone
Dosage form
SUSPENSION
Route
ORAL
Labeler
AvPAK
Application
ANDA210692
Marketing category
ANDA
Marketing start
2020-05-07
Marketing end
0000-00-00
Substance
ATOVAQUONE
Active strength
750 mg/5mL
Pharmacologic classes
Antimalarial [EPC], Antiprotozoal [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50268-086DDiscontinued by firm2026-07-31
excluded packagepackage50268-08650268-086-12DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210692-001ATOVAQUONEATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A210692-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A210692-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtovaquoneATOVAQUONECamber Pharmaceuticals, Inc.2445304e-4b4e-4358-b098-31f3c49c52ef2026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210692
application number: ANDA210692
AtovaquoneATOVAQUONEAmerican Health Packaging1a8a43a2-bc26-4ee5-aa35-22a5477a71292025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210692
application number: ANDA210692
AtovaquoneATOVAQUONEATLANTIC BIOLOGICALS CORP.40331de7-819e-5965-e063-6294a90ac91d2025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210692
application number: ANDA210692
AtovaquoneATOVAQUONEATLANTIC BIOLOGICALS CORP.f99a8a0c-2b42-4da0-8f5a-e963fc619e8b2025-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210692
application number: ANDA210692
AtovaquoneATOVAQUONELohxaba3cad0d-cce9-424f-ba5c-557dba8bef122025-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210692
application number: ANDA210692
AtovaquoneATOVAQUONENorthStar RxLLCfc7bdd97-f780-4eed-80e0-72e70267b21a2024-04-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210692
application number: ANDA210692
ATOVAQUONEATOVAQUONELupin Pharmaceuticals, Inc.03ddcc33-729c-4d46-ae6b-2ee47978ba162021-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210692
application number: ANDA210692

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50268-086-122025-07-29C16284748780-1d6a99b39-3c79-a426-e053-dadaa90af4c2Atovaquone Oral Suspension, USP Rx Only These highlights do not include all the information needed to use ATOVAQUONE ORAL SUSPENSION safely and effectively. See full prescribing information for ATOVAQUONE ORAL SUSPENSION. Initial U.S. Approval: 1992
50268-086-122022-01-30C16284748780-1d6a99b39-3c79-a426-e053-dadaa90af4c2Atovaquone Oral Suspension, USP Rx Only These highlights do not include all the information needed to use ATOVAQUONE ORAL SUSPENSION safely and effectively. See full prescribing information for ATOVAQUONE ORAL SUSPENSION. Initial U.S. Approval: 1992
50268-086-122022-01-28C16284748780-1d6a99b39-3c79-a426-e053-dadaa90af4c2Atovaquone Oral Suspension, USP Rx Only These highlights do not include all the information needed to use ATOVAQUONE ORAL SUSPENSION safely and effectively. See full prescribing information for ATOVAQUONE ORAL SUSPENSION. Initial U.S. Approval: 1992

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-086-11ML - Milliliter50268-0869970e297-9208-456f-b579-e8336667466012020-06-05
50268-086-12ML - Milliliter50268-0866fd99c2c-c200-4fa4-a364-7df1d698e20a12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-086ATOVAQUONE SUSPENSION [AVPAK]3Legacy NDC20240110_a50fb7df-6f2d-63f9-e053-2a95a90ad9d3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50268-086-125026800861220 CUP, UNIT-DOSE in 1 BOX (50268-086-12) > 5 mL in 1 CUP, UNIT-DOSE (50268-086-11) 2020-05-070000-00-00NoNoCurrent